The second and third phases of the clinical study on the safety and efficacy of the plant-based anti-dengue drug will start in September this year, and "will be completed within a year", the Department of Science and Technology (DOST) said on Friday, Aug. 20.
DOST Undersecretary for Research and Development (R&D) Dr. Rowena Cristina L. Guevara said the first phase of the trial on the use of anti-dengue capsule has already been completed and yielded promising results.
The project is entitled “Efficacy and Safety of Orally Administered Fixed Dose Combination Capsule of RGA02 + JRA01 + ASB02 in the Treatment of Dengue Without Warning Signs Among Adult Filipinos in Cavite: A Randomized, Double-blind, Placebo Controlled Trial.” Led by Dr. Josefino Alvero, president of the Pharmalytics Corporation, the study is funded by the DOST–Philippine Council for Health Research and Development (PCHRD)
Guevara said a Phase I safety study was conducted to determine the maximum tolerable dose of the fixed-dose combination capsule, which was developed using three plants and underwent subsequent acute and sub chronic toxicity testing in animals.
"Results showed that among the adverse events reported, all were considered transient, bearable and did not lead to withdrawal of participants from the study. With the maximum dose given, there were no serious adverse events nor dose limiting toxicities noted even in any of the lower doses,” she told the Manila Bulletin.
“With these promising results implying safety of the capsules, a Phase 2/3 clinical trial will be conducted to further assess its efficacy among dengue patients.”
She said the project team is preparing for the start of the “Phase 2/3 clinical trial.”
Phase 2/3 trial is a combination of second and third phases aimed at expeditiously securing information on the efficacy and safety of the anti-dengue medicine.
“Currently, the project team is preparing for the commencement of the clinical trial Phase 2/3 of the study which is expected to start this September and will be completed within a year,” Guevara said.
She said the study will be conducted in several hospitals in Cavite with high cases of dengue disease.
“If proven safe and effective, this will be the first definitive treatment for Dengue which is now a significant public health burden and will pave the way for its use in Dengue with warning signs and even in severe cases of dengue,” she said.
"Dengue is a mosquito-borne infection that has been steadily increasing in incidence in recent years. It is considered as one of the top health problems in the Philippines and in most tropical countries of the world yet no specific therapeutic agent is available to date,” the DOST official noted.
The Department of Health (DOH) reported that in 2020, it recorded 83,335 dengue cases, of which 324 died.
In 2019, a national dengue epidemic was declared in the country due to spike in cases of the mosquito-borne disease after logging 437,563 cases with 1,689 deaths.